This calculation shows the effect of a 1% assay difference between for example
Purimox and the average chemical Amoxicillin.
Using Purimox ® instead of Chemical Amoxicillin would result in:
Increased output of 1% (16 capsules) per kg of Amoxicillin
Reduced API
use of 1% (50 grams per 1000 capsules)
Hardly any dust-formation
The product lost due to
dust-formation when the API is added to the machine is in the case of chemical
Amoxicillin up to 2%. This loss is strongly reduced by using API’s with less
fine particles, like Purimox®
More exact & efficient dosing
Thanks to the high stability
of DSMPureActives™, the assay of the ingredient stays within pharmacopoeia
limits for a longer period of time. This means that the amount of ingredient
that is needed at the moment of formulation is much closer to the amount that
is guaranteed at the end of shelf life.
Formulators can materialize this advantage by reducing the amount of excess
material that is dosed into the dosage form to guarantee the end of shelf life
activity.
Reduce your costs for testing and administration!
Our batch
size is up to 10 times as large compared to chemical alternatives. Resulting,
tests that are performed on incoming batches can be reduced by a similar
factor. In addition, the limited number of impurities reduces the number of
different tests that need to be performed per batch.
DSMPureActivesTM simplify the registration process
A typical
characteristic of all DSMPureActives™ products is the reduced number of
impurities. During the registration process formulators are frequently asked
for additional information about impurities found in the active ingredient. As
the number of impurities in DSMPureActives™ is less than in the chemically
produced alternatives, the efforts and costs needed for new registration and
maintenance of existing dossiers can be reduced.
A longer shelf life reduces your supply chain costs
The most
important aspect is the long shelf life whereby obsoletes can be reduced.
Another aspect is the large batch size, which reduces the amount of
administrative work and utilization of IT resources. In case the formulator is
able to translate the longer shelf life of the API into a longer shelf life of
his formulated product, this will result in reduced obsoletes in the
down-stream value chain (distribution and pharmacies).
Increase your operator comfort
Operators in the formulation
industry are in daily contact with the active pharmaceutical ingredient.
Companies take thorough Safety and Health precautions to minimize this contact
and the impact of the contact. By using DSMPureActives™, the comfort in use
for operators will be further optimized; the smell spread by the product is
much less aggressive thanks to the absence of residual solvents and thanks to
the physical properties of some of the DSMPureActives™ grades, the product
generates less dust when added to machines.
